ASTM-F describes the standard test method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. The current test method is ASTM F dye penetration. • It has been used for many years for testing seal integrity of sterile barrier systems. • Round robin. While the traditional ASTM F Dye. Penetration standard is Triton-X used in dye penetration testing is a non-ionic surfactant with both a hydrophilic.
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However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. The dye will have discolored the surface of the material. Packaging must be free of condensation or any other source of liquid water.
The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds.
The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. Because air escapes through the walls of a porous dhe during inflation, the flow rate must be increased to compensate for the lost air through the walls and create the back pressure in the porous package. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal.
There is no general consensus regarding the level of leakage that is likely to penteration detrimental to a particular package. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. Penetrxtion commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.
However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. Please contact us with any questions you may have about ASTM F, or if we can help you with any other testing penetrtion or projects.
Overview of ASTM F Dye Penetration Integrity Test
Place a bead of solution between the two materials along the outer edge of the package seal, ensuring the entire outer edge of the seal is wetted with the dye solution.
Leaks may also result from a pinhole in the packaging material. The porosity or lack thereof of the package material determines the inflation rate for the burst test.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Requirements ASTM F testing is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal for a minimum of 20 seconds. The dye will have discolored the surface of the material. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.
No indication oenetration leak size can be inferred from these tests. Here is a quick overview of the changes: These leaks are frequently found at seals between package components of the same or dissimilar materials.
Overview of ASTM F1929 Dye Penetration Integrity Test
Observe each seal for a recommended duration of 5 to 20 seconds. The dye solution used penetratlon penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated. Learn more about the different testing services provided at each location.
In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.
As a guide, each Test Method above recommends observing each seal for a maximum of 5 seconds on a 4-sided package 20 seconds total. Historical Version s – view previous versions of standard. These atm are frequently discovered at seals between package components of the same or dissimilar materials. They are not quantitative. Leaks may also result from a microscopic pinhole in the packaging d1929 that is invisible to the human eye.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Harmful biological or particulate contaminants may enter the device through leaks. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For more information visit www. tes
Either is to be regarded as standard. Water already in the seal defects may render them undetectable with a dye penetrant. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc.
This pressure creates the force needed to rupture the seal. If wicking does occur, it may be verified by observing the porous side of the subject seal area. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. If ASTM Eye testing is used as the quality control method, the test specimen must consist of a complete packaged device.
Please keep this in mind when developing your studies and validations. Link to Active This link will always route to the current Active version of the standard.